Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Magnhild Kverneland, Oslo University Hospital Identifier:
First received: March 7, 2011
Last updated: March 29, 2017
Last verified: March 2017

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.

We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

Condition Intervention
Focal Epilepsy
Generalized Epilepsy
Other: Modified Atkins diet treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change in seizure frequency [ Time Frame: 12 weeks ]
    All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: 12 weeks ]
  • Change in standard 3-hrs EEG [ Time Frame: 12 weeks ]
  • Change in life quality measured by validated questionnaire [ Time Frame: 12 weeks ]
  • Change in various blood and serum measures [ Time Frame: 12 weeks ]
  • Change in executive functions measured with validated questionnaire [ Time Frame: 12 weeks ]
  • Change in seizure strength and severity measured by validated questionnaire [ Time Frame: 12 weeks ]

Enrollment: 75
Actual Study Start Date: March 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Atkins diet treatment
12 weeks of Modified Atkins diet treatment, recording seizures
Other: Modified Atkins diet treatment
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
No Intervention: No intervention
12 weeks seizure record

Detailed Description:

Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.

Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.

We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.

During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Focal or generalized epilepsy diagnosis
  • More than 3 recordable seizures per month
  • BMI > 18,5
  • Not responded to at least three 3 AEDs
  • 16 years or older
  • Motivated to complete the diet after thorough information
  • Capable of recording seizures
  • Capable of preparing the diet

Exclusion Criteria:

  • Hypercholesterolemia, cardiovascular disease or kidney disease
  • Been on modified Atkins diet for more than one week during the last year
  • Status epilepticus last six months
  • epilepsy surgery or VNS implant last year
  • 4 weeks continuous seizure freedom last 2 months
  • PNES seizures
  • other disease where dietary treatment is contraindicated
  • usage of drugs or supplements that may interfere with diet or AED
  • being pregnant or planning pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01311440

Oslo University Hospital, The national Centre for epilepsy
Sandvika, Bærum Postterminal, Norway, 1306
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Karl Otto Nakken Oslo University Hospital
  More Information

Responsible Party: Magnhild Kverneland, Registered Nutritionist, Oslo University Hospital Identifier: NCT01311440     History of Changes
Other Study ID Numbers: 2010/2326 (REK)
Study First Received: March 7, 2011
Last Updated: March 29, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Oslo University Hospital:
modified Atkins diet
ketogenic diet

Additional relevant MeSH terms:
Epilepsy, Generalized
Drug Resistant Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 26, 2017